BMS and Pfizer Receive FDA Approval for Eliquis Sprinkle, a Pediatric VTE Treatment
A New Formulation for Pediatric Patients
The FDA has approved Eliquis Sprinkle (apixaban), a pediatric formulation of Bristol Myers Squibb (BMS) and Pfizer's anticoagulant, for the treatment of venous thromboembolism (VTE) and the reduction of the risk of recurrence in pediatric patients from birth to under 18 years of age. This approval marks a significant milestone, as Eliquis, which already holds a leading position in the adult VTE treatment market, expands its reach to include pediatric patients through formulation diversification.
Formulation Diversification and Clinical Safety
Eliquis Sprinkle is a specially designed formulation that allows the capsule to be opened and mixed with water or other liquids, making it easier for pediatric patients who have difficulty swallowing pills. In a clinical trial (NCT02464969), Eliquis demonstrated excellent safety and consistent pharmacokinetic properties in pediatric patients compared to standard treatment. It also showed stable anticoagulant efficacy without significantly increasing the risk of major bleeding, a common concern in pediatric patients, leading to regulatory approval.
Competitive Landscape in the Pediatric DOAC Market
Previously, the pediatric VTE market was dominated by Bayer and Johnson & Johnson's Xarelto (rivaroxaban), which received pediatric approval in 2021. With the approval of Eliquis Sprinkle, a full-fledged competition has begun in the pediatric oral direct-acting anticoagulant (DOAC) market. The sprinkle formulation, which maximizes convenience, is expected to be a strong differentiator in the pediatric anticoagulant market, where a significant number of patients are hospitalized.
Partnership Success and Value Creation
This approval is the result of a successful global alliance between BMS and Pfizer, which effectively addresses the unmet medical needs in the niche area of pediatric diseases. Eliquis, a blockbuster drug with annual sales exceeding $14 billion, is successfully extending its product lifecycle through formulation diversification in anticipation of patent expiration. Although the pediatric patient market is smaller than the adult market, securing this high-value niche market and strengthening the portfolio are expected to contribute positively to the revenue growth of both companies.
This approval will be a key turning point in breaking the monopoly of Xarelto, which preempted the pediatric indication in 2021, in the $14.4 billion blockbuster drug market. The sprinkle formulation, which has proven its safety through a Phase 3 clinical trial (NCT02464969) for pediatric VTE, will cover a wide range of patients from newborns to those under 18 years of age who have limitations in taking medication. In the short term, it is expected to increase prescriptions through rapid entry into the formularies of pediatric specialist medical institutions, and in the medium to long term, it will serve as a strategy to strengthen formulation patent barriers in preparation for patent expiration. Securing the pediatric segment in the global VTE treatment market, which is expected to grow to $7 billion by 2034, will be an opportunity to reaffirm the partnership value between BMS and Pfizer.
Source: openFDA (api_fda)
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA220073